Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

adalimumab

Study hypothesis

To evaluate the response to adalimumab treatment in Tumour Necrotising Factor (TNF)-alpha blockade naÏve patients and patients who failed prior other anti-TNF-alpha treatment and to understand the mechanisms underlying the clinical response to TNF-alpha blockade.

Ethics approval

Approval received from the Medical ethical committee of the Academic Medical Center/University of Amsterdam on the 12th February 2004 (ref: MEC04/007).

Study design

Single-centre open label prospective, exploratory phase IV study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Adalimumab 40 mg subcutaneously once every two weeks.

Intervention type

Drug

Phase

Phase IV

Drug names

Adalimumab

Primary outcome measures

1. Clinical efficacy according to the EUropean League Against Rheumatism (EULAR) response criteria at week 16 after initiation of treatment2. Exploration of clinical and serological markers that might distinguish responding from non-responding patients (e.g. the influence of anti-adalimumab antibody formation and adalimumab concentrations on response)

Secondary outcome measures

1. Clinical efficacy according to the EULAR response criteria at week 40 and 52 after initiation of treatment2. Exploration of genetic markers (e.g. cytokine polymorphisms) that are associated with clinical efficacy3. The effects of adalimumab on bone mineral density as measured by Dual Energy X-ray Absortiometry (DEXA) scanning4. The effects of adalimumab on lipid metabolism as measured by fasting serum lipid profiles in time5. The effects of adalimumab on work productivity and sick leave measured by work-related questionnaires during 52 weeks follow-up

Overall trial start date

07/04/2004

Overall trial end date

07/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in American College of Rheumatology (ACR) 1991 functional classes I, II, and III 2. The patient is naÏve for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers3. Disease Activity Score (DAS 28) more than or equal to 3.24. Age 18 to 85 years old5. Use concurrent methotrexate treatment (5 - 30 mg/week stable since at least 28 days before initiation) during the study. Subjects may be taking nonsteroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy less than or equal to 10 mg/day rovided that the dosage has been stable for at least two months prior to entry

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

1. Pregnancy2. Breastfeeding3. A history of or current acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years4. Acute major trauma5. Therapy within the previous 60 days with:a. any experimental drugb. alkylating agentsc. antimetabolitesd. monoclonal antibodies (including infliximab and etanercept)e. growth factorsf. other cytokines6. Therapy within the previous 28 days with:a. parenteral or intra-articular corticoid injectionsb. oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg dailyc. present use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate7. Receipt of any live (attenuated) vaccines within four weeks prior to baseline8. Fever (orally measured more than 38°C), chronic infections or infections requiring anti-microbial therapy9. Known positive reaction to hepatitis B surface antigen or hepatitis C antigen10. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus11. Manifest cardiac failure (stage III or IV according to New York Heart Association [NYHA] classification)12. Progressive fatal disease/terminal illness13. A congenital or acquired (known Human Immunodeficiency Virus [HIV]-positive status) immunodeficiency14. A history of lymphoproliferative disease or treatment with total lymphoid irradiation15. A white cell count less than 3.5 x 10^9/l16. Platelet count less than 100 x 10^9/l17. Haemoglobin of less than 5.3 mmol/l18. Body weight of less than 45 kg19. History of drug or alcohol abuse20. Any concomitant medical condition which would in the investigator's opinion compromise the patient's ability to tolerate, absorb, metabolise or excrete the study medication21. Inability to give informed consent22. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude